Sunglasses and the FDA

If you are importing sunglasses or other eyewear to the U.S. (whether or not you are AWARE that you're importing!), you will have to obtain release from the Food & Drug Administration (FDA) as well as U.S. Customs. Whether you are importing a single pair for personal use or larger amounts for commercial purposes, there are documents and details that will be required to clear your shipment into the country. We will look at personal shipments of eyewear in this article.

Online shopping being what it is these days, more and more often, your online vendor may have an out of country supplier. That doesn't necessarily mean your shades will come from outside the country, but it could. Drop-shipping is a very economical way for online vendors to handle their delivery needs, where by they take and process your order and then have a supplier handle the shipping details. When this happens with a foreign supplier, guess what, you, the consumer, become an importer! Should this become the case, you will likely be contacted by the carrier for additional details in order to clear U.S. Customs and obtain FDA release of your goods.

Sunglasses and other eyewear require some specific documentation for entry to the United States that ideally should be prepared by the shipper and included with the other shipping documents that are sent along with your shipment. These include either an impact resistance test document or a drop ball test document with results of both. The two are mostly interchangeable, but there are slight differences in the two. For the purpose of this article, it isn't important to take that into account, however. Just know that the FDA will require this in most cases, even for single pairs of glasses for personal use.

In addition to the drop ball test, eyewear, specifically the frames, must be given an FDA Medical Device List (MDL) number. It is a proprietary number issued by the FDA to the manufacturer and is often required even for a personal shipment. As a side note, you may have noticed I use the word "often" and "usually" frequently and there's a reason for that. Every entry port in the country is different when it comes to Customs, the FDA, and other governmental agencies. Each port's inspectors and investigators are given a certain amount of interpretation of the rules and regulations that govern the importation of any goods under their jurisdiction, so it makes it quite difficult to make categorical statements regarding nearly anything that you might be importing. There are however some fairly hard and fast rules. With FDA being prodded by U.S. Congress to enforce existing regulations, you might as well be prepared to meet the requirements as strictly interpreted!

So, the drop ball test and the MDL, which needs to be on the commercial invoice, by the way, are both to be provided by the foreign supplier. Whether they will be or not is frankly hit or miss. My suggestion to you is that if you're buying from an online vendor, find out BEFORE you make the purchase if the goods are going to be drop shipped from out of the country. Being prepared for that is far better than finding out your purchase is being held in a bonded warehouse for further information. Now, what might U.S. Customs or the FDA require you to provide?

For reasons I'm about to explain, often an FDA regulated shipment will get a "formal entry" through U.S. Customs. In such cases, the importer (that being you) will be required to provide tax ID information and/or documentation. Since this is a personal shipment, that means your social security number. While this may seem invasive, I can assure you, it really is a Customs requirement for many, many shipments. You can read more about providing your social security number at another article I've written here.

To conclude, if you find yourself accidentally importing because you bought a pair of hot shades online, knowing these few things about the import process will go a long way in making it a simpler, less annoying experience.